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Common Painkillers Can Be Dangerous, FDA Warns

Agency Urges Consumers To Follow Label Instructions

Posted: 1:19 p.m. EST January 23, 2004

Ignoring the directions and misusing over-the-counter painkillers can result in severe side effects -- including death, says the Food and Drug Administration in a new consumer education campaign.

 SURVEY
Do you follow label instructions with over-the-counter pain medications?
Yes, all the time.
Yes, if I'm unfamiliar with the drug.
No, I've taken them often enough to know my dosage.
No, I rarely read label instructions.
"Pain relievers and fever reducers are safe drugs when used as directed, but they can cause serious problems when used by people with certain conditions or those who are taking specific medicines," said Dr. Mark McClellan, FDA commissioner. "We want to remind consumers who take these products that it's important to follow current dosing and label directions carefully."

The FDA says the biggest problem is taking too much of the popular drug acetaminophen, which is best known under the Tylenol brand. An overdose can poison the liver.

While some 100 million people a year take acetaminophen, manufacturers insist that serious liver damage is rare. Still, more than 56,000 emergency room visits a year are due to acetaminophen overdoses. And, according to government estimates, about 100 people a year die after unintentionally taking too much.

Other over-the-counter drugs getting attention in the campaign include aspirin, ibuprofen and naproxen -- nonsteroidal anti-inflammatory drugs. Those side effects include stomach bleeding and kidney problems.

The agency says that many over-the-counter medicines sold for different uses have the same active ingredient. For example, a cold-and-cough remedy may have the same active ingredient as a headache remedy or a prescription pain-reliever. Consumers should be on the lookout for this and avoid taking multiple medications with the same active ingredient at the same time.